Infection control is of serious concern in hospitals, laboratories and other health care facilities. The prevention of health risks to staff and patients is of the highest priority. Contaminated instruments, especially surgical instruments, can be a source of infection transmission and cross contamination. The most common types of contaminants found on instruments are blood, body fluids, tissue and surgical residue, soil, bacterial and viral mass. The most stubborn contaminant on surgical instruments and the one which is the hardest to remove is normally coagulated blood. As defined in ANSI/AAMI ST35 (1996), “contaminated” means the state of having been actually or potentially in contact with microorganisms. As used in health care, the term generally refers to microorganisms that might be capable of producing disease or infection. As also defined therein, “decontamination” is defined as follows: “[T]he use of physical or chemical means to remove, inactive, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use or disposal” [29 CFR 1910.1030]. The term is generally used in health care facilities with reference to all pathogenic organisms, not just those transmitted by blood.
In addition to causing infection and cross contamination, these contaminants also cause pitting, staining, and corrosion of the instruments if the contaminants are left on the instruments for any extended period of time, especially if the contaminant residues are allowed to dry. The most damaging procedure is to allow dried-on residues to become baked-on stains in the sterilization autoclave. The temperature of the autoclave (250°-270°) will cause chemical reactions that can make the stain permanent. Therefore, thorough pre-sterilization washing of the contaminated instruments shortly after surgery is the best defense against cross contamination and instrument corrosion, pitting, and staining caused by such contaminant residues.
Instruments are a major asset and represent a significant investment by a hospital, health care provider or laboratory. In addition, medical professionals want to ensure the utmost quality and integrity of their surgical instruments at all times and therefore damaged instruments are unacceptable. The cost of replacing surgical instruments is far greater than the cost of maintaining them by proper cleaning and maintenance. Considering that surgical instrument trays for major surgeries can bear price tags of $20,000 or more and that individual instruments can cost several hundred dollars each, sterile processing (SP) technicians must be well versed in the care and handling of surgical instruments and must engage in preventive maintenance. A properly cleaned and reprocessed instrument is to a surgeon what a chisel and hammer is to a sculptor: a set of tools worthy of respect and critical to the outcome of the professional's surgical or creative endeavor.
Contaminated surgical instruments are typically processed as follows: First, there is a cleaning (or pre-disinfection) by substantially eliminating the contaminants by efficient cleaning and bio-cleansing. Next, the instruments are disinfected followed by sterilization in an autoclave. To ensure sterile integrity, the instruments are then stored in sterile conditions. Therefore, the cleaning step is the linchpin of an effective disinfection and sterilization process. If the instruments are not clean, they cannot be sanitized, disinfected or sterilized with any certainty. An autoclave does not clean; it will only sterilize.
Cleaning may be performed manually, mechanically, or by using a combination of both methods. Recommendations suggest that a three deep sink configuration be used for manual cleaning. The first sink is the wash sink which contains the cleaning solution. The second sink is typically the rinse sink designed to remove any detergent or remaining residue. A third sink may be needed for the final rinse with distilled or deionized water to prevent spotting on the instrumentation.
Automated mechanical pre-sterilization cleaning by washer sanitizers has become the choice of most hospitals, health care providers and laboratory practitioners. Washer sanitizers for medical and laboratory purposes have a rinse and washing cycle for removing contaminants with the use of detergents or the like. The washer sanitizers typically include one or more racks designed to hold instrument trays (also known as “decontamination pans”). The washer sanitizer mechanically cleans instruments by a spray action known as impingement from sprayers (not shown) inside the washer sanitizer. Impingement is the water force making contact with the instrument. Each type of impingement system also requires a specialized detergent formulation.
Ultrasonic cleaners are another type of mechanical washer, designed for fine cleaning of medical devices to remove contaminants from hard to reach areas like crevices, joints, grooves, hinges, box locks, etc. Gross contaminants must be removed from instruments before processing in the ultrasonic cleaner because heavy contamination can inhibit the cleaning activity.
In the past, contaminated instruments have been haphazardly laid at the bottom of the instrument trays after opening the instruments to expose the hard to reach areas to the cleaning process. The instrument trays are then put on the one or more racks in the washer sanitizer. Attempts to improve this cleaning process have included the use of instrument string members and other devices. Instrument String members have been used to hold the instruments open in the instrument tray with the instruments stacked horizontally on top of one another.
Unfortunately, these practices (including open contaminated instruments on the bottom of the instrument tray, strung onto instrument string members, etc.) have not provided sufficient cleaning, especially for the hard to reach areas of surgical instruments. In addition, these practices also subject the instruments to a risk of damage as they contact each other during the cleaning process. The instruments may also fall off of the instrument string members during the cleaning process.
In addition to pre-sterilization cleaning, instruments should be lubricated regularly after cleaning and before autoclaving as part of a maintenance regimen. Proper lubrication keeps instruments from rubbing and scraping, thus preventing dulling and strain to joints and hinges. Lubricants may be applied during mechanical processing cycles, such as within the washer-sanitizer.
There is therefore for an instrument holding assembly and method that substantially increase the efficiency of pre-sterilization cleaning to substantially minimize infection rates and cross contamination. There is another need for an assembly and method that substantially permit proper positioning of the instruments and better exposure of the hard to reach instrument areas for optimal cleaning and lubrication. There is an additional need for an assembly and method that substantially prevent instrument damage from contaminant residues and during cleaning thus protecting the value of the instrument and lessening repairs and replacement thereof thus substantially reducing the overall instrument inventory. The present invention fulfills these needs and provides other related advantages.